A comparison of cyanoacrylate glue and radiofrequency ablation techniques in the treatment of superficial venous reflux in CEAP 6 patients

Published:January 12, 2021DOI:https://doi.org/10.1016/j.jvsv.2020.12.082

      Abstract

      Objective

      Venous leg ulcers (CEAP [clinical, etiologic, anatomic, pathophysiologic] class 6) represent the most severe form of chronic venous insufficiency. As closure techniques for superficial venous reflux evolve, direct outcome comparisons of treatments are integral, because many studies have already demonstrated that early endovenous intervention improves wound healing. The present study compared the rates of venous wound healing between two techniques of superficial vein closure: ClosureFast radiofrequency ablation (RFA) and adhesive closure (VenaSeal; both Medtronic, Inc, Minneapolis, Minn).

      Methods

      We performed a multi-institutional retrospective review of all patients with CEAP class 6 who had undergone closure of their truncal veins from 2015 to 2020. Patients undergoing ClosureFast RFA were compared with those undergoing VenaSeal adhesive closure. The primary endpoint was the interval to wound healing from initial vein closure. The secondary endpoints included ulcer recurrence and infection rates. Bivariate analysis involved the χ2, Fisher exact, t, and Wilcoxon rank sum tests. Multivariate linear regression analysis was used to examine the factors affecting the time to wound healing in the most predictive model. Statistical significance was defined as P < .05.

      Results

      A total of 119 patients with CEAP 6 were included, with a median follow-up of 105 days (interquartile range, 44-208 days). Of the 119 limbs, 68 were treated with RFA and 51 with VenaSeal. Significantly more patients undergoing RFA had had a history of deep vein thrombosis (29% vs 10%; P = .01) and deep venous reflux (82% vs 51%; P = .003). The VenaSeal patients were older (72 years vs 65 years; P = .02) with a greater rate of coronary artery disease (16% vs 37%; P = .01). The median time to wound healing after the procedure was significantly shorter for VenaSeal than for RFA (43 vs 104 days; P = .001). Two RFA patients developed a postprocedure infection. The ulcer recurrence rate was 19.3% (22.1% for RFA vs 13.7% for VenaSeal; P = .25). On multivariate analysis, the treatment modality was the only significant predictor of the time to wound healing. When stratified by ulcer size as small (<3 cm2) vs large (>3 cm2), VenaSeal closure healed the wounds significantly faster for all ulcers.

      Conclusions

      ClosureFast and VenaSeal are both safe and effective treatments to eliminate truncal venous insufficiency. VenaSeal showed a superior time to wound healing compared with ClosureFast in both large and small ulcers.

      Graphical abstract

      Keywords

      To read this article in full you will need to make a payment
      SVS Member Login
      Society Members, full access to the journal is a member benefit. Use your society credentials to access all journal content and features
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Purchase one-time access:

      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • O'Donnell Jr., T.F.
        • Passman M.A.
        • Marston W.A.
        • Ennis W.J.
        • Dalsing M.
        • Kistner R.L.
        • et al.
        Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum.
        J Vasc Surg. 2014; 60: 3S-59S
        • Abbade L.P.
        • Lastoria S.
        Venous ulcer: epidemiology, physiopathology, diagnosis and treatment.
        Int J Dermatol. 2005; 44: 449-456
        • Rice J.B.
        • Desai U.
        • Cummings A.K.
        • Birnbaum H.G.
        • Skornicki M.
        • Parsons N.
        Burden of venous leg ulcers in the United States.
        J Med Econ. 2014; 17: 347-356
        • Barwell J.R.
        • Davies C.E.
        • Deacon J.
        • Harvey K.
        • Minor J.
        • Sassano A.
        • et al.
        Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial.
        Lancet. 2004; 363: 1854-1859
        • Gohel M.S.
        • Heatley F.
        • Liu X.
        • Bradbury A.
        • Bulbulia R.
        • Cullum N.
        • et al.
        A randomized trial of early endovenous ablation in venous ulceration.
        N Engl J Med. 2018; 378: 2105-2114
        • Kiguchi M.M.
        • Dillavou E.D.
        Thermal and nonthermal endovenous ablation options for treatment of superficial venous insufficiency.
        Surg Clin North Am. 2018; 98: 385-400
        • Chan S.S.J.
        • Yap C.J.Q.
        • Tan S.G.
        • Choke E.T.C.
        • Chong T.T.
        • Tang T.Y.
        The utility of endovenous cyanoacrylate glue ablation for incompetent saphenous veins in the setting of venous leg ulcers.
        J Vasc Surg Venous Lymphat Disord. 2020; 8: 1041-1048
        • Morrison N.
        • Gibson K.
        • Vasquez M.
        • Weiss R.
        • Jones A.
        Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins.
        J Vasc Surg Venous Lymphat Disord. 2020; 8: 978-989
        • Delis K.T.
        • Ibegbuna V.
        • Nicolaides A.N.
        • Lauro A.
        • Hafez H.
        Prevalence and distribution of incompetent perforating veins in chronic venous insufficiency.
        J Vasc Surg. 1998; 28: 815-825
        • Marston W.A.
        • Ennis W.J.
        • Lantis II, J.C.
        • Kirsner R.S.
        • Galiano R.D.
        • Vanscheidt W.
        • et al.
        Baseline factors affecting closure of venous leg ulcers.
        J Vasc Surg Venous Lymphat Disord. 2017; 5 (829-35.e1)
        • Harlander-Locke M.
        • Lawrence P.
        • Jimenez J.C.
        • Rigberg D.
        • DeRubertis B.
        • Gelabert H.
        Combined treatment with compression therapy and ablation of incompetent superficial and perforating veins reduces ulcer recurrence in patients with CEAP 5 venous disease.
        J Vasc Surg. 2012; 55: 446-450
        • Harlander-Locke M.
        • Lawrence P.F.
        • Alktaifi A.
        • Jimenez J.C.
        • Rigberg D.
        • DeRubertis B.
        The impact of ablation of incompetent superficial and perforator veins on ulcer healing rates.
        J Vasc Surg. 2012; 55: 458-464
        • Scotton M.F.
        • Miot H.A.
        • Abbade L.P.
        Factors that influence healing of chronic venous leg ulcers: a retrospective cohort.
        An Bras Dermatol. 2014; 89: 414-422
        • Margolis D.J.
        • Berlin J.A.
        • Strom B.L.
        Risk factors associated with the failure of a venous leg ulcer to heal.
        Arch Dermatol. 1999; 135: 920-926
        • Kolluri R.
        • Chung J.
        • Kim S.
        • Nath N.
        • Bhalla B.B.
        • Jain T.
        • et al.
        Network meta-analysis to compare VenaSeal with other superficial venous therapies for chronic venous insufficiency.
        J Vasc Surg Venous Lymphat Disord. 2020; 8 (472-81.e3)

      Linked Article

      • Deep vein insufficiency, not the method choice, determines the outcome of endovascular treatment in CEAP 6 patients
        Journal of Vascular Surgery: Venous and Lymphatic DisordersVol. 9Issue 6
        • Preview
          We have read two interesting reports recently published in JVS-VLD by O'Banion et al.1,2 In the first paper, the authors described a short-term outcome of superficial venous reflux treatment using cyanoacrylate (CA) or radiofrequency (RF) ablation in CEAP 6 patients.1 The second paper concerned the auxiliary perforator treatment in the same patients in the follow-up period.2 In both papers, the authors concluded that CA shows superiority over RF in time required to wound healing1 and requires less perforator interventions.
        • Full-Text
        • PDF